Surgical planning system and method

ABSTRACT

A system and method to receive a request for a patient-specific surgical plan, create the requested plan, and provide it to a surgeon is disclosed. A Planning server may receive patient-specific information and statistical information, and an order from a surgeon for a surgical plan. A Plan Development client may include a surgical planning module that may create an electronic surgical plan based on the patient-specific information and the statistical information, and may transmit the plan to the Planning server. The ordering surgeon may be notified of the availability of the plan, and may access the plan stored at the Planning server through a surgeon client. The ordering surgeon may utilize the remotely generated surgical plan during the surgical procedure on the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of patent application Ser. No.16/740,940, filed Jan. 13, 2020, which is a continuation of patentapplication Ser. No. 13/225,246, filed Sep. 2, 2011, now U.S. Pat. No.10,540,479, which claims priority from Provisional Patent ApplicationSer. No. 61/508,559, filed Jul. 15, 2011, the applications of which arehereby incorporated by reference herein in their entireties.

SUMMARY OF THE INVENTION

Briefly, the present invention relates to a system and method forreceiving a request for one or more patient-specific surgical plans,creating the requested plans, and providing the plans to an orderingsurgeon. As part of the request for a surgical plan, a Planning servermay receive information regarding a patient, such as one or more digitalimages of the portion of the patient's anatomy that is to be operatedon. The Planning server may also receive an order from a surgeon, animaging technologist, or a sales representative, among others, for asurgical plan. A Plan Development client may include a surgical planningmodule that accesses the one or more digital images from the Planningserver, and creates a computer-generated, three-dimensional model of thepatient anatomy. The planning module of the Plan Development client alsomay create an electronic surgical plan, and may transmit the plan to thePlanning server. The ordering surgeon may be notified of theavailability of the plan, and may access the plan stored at the Planningserver through client device associated with the surgeon. The orderingsurgeon may review, modify according to specific needs, and utilize theremotely generated surgical plan during the surgical procedure on thepatient.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention description below refers to the accompanying drawings, ofwhich:

FIG. 1 is a highly schematic illustration of an environment inaccordance with an embodiment of the present invention;

FIG. 2 is a schematic illustration of a server in accordance with anembodiment of the present invention; and

FIG. 3 is a functional block diagram of a server in accordance with anembodiment of the present invention.

FIG. 4 is a functional block diagram of an ordering surgeon client inaccordance with an embodiment of the present invention;

FIG. 5 is a functional block diagram of a plan development client inaccordance with an embodiment of the present invention;

FIGS. 6A and 6B are a flow diagram of a method in accordance with anembodiment of the present invention;

FIG. 7 is a schematic illustration of a request web page in accordancewith an embodiment of the present invention;

FIG. 8 is a schematic illustration of a data record in accordance withan embodiment of the present invention;

FIG. 9 is a schematic illustration of a surgical plan upload web page inaccordance with an embodiment of the present invention;

FIG. 10 is a schematic illustration of a surgical plan download web pagein accordance with an embodiment of the present invention; and

FIG. 11 is a schematic illustration of a surgical plan in accordancewith an embodiment of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

FIG. 1 is a schematic illustration of an environment 100 in which thepresent invention may be utilized. The environment 100 may include aPlanning server 102 that may be coupled to a communication network 104.Also coupled to the communication network 104 may be a plurality of dataprocessing devices that are associated with hospitals, operating rooms,and/or surgeons. Specifically, a Radiology client 106 may be located ina Radiology department of a hospital at which a surgical procedure, suchas total hip replacement (THR) surgery, will be performed on a patient.An Ordering Surgeon client 108 may be located in the office of thesurgeon that will be performing the procedure. An Operating Room (OR)client 110 may be located in an operating room of the hospital at whichthe surgical procedure will be performed. Clients 106, 108, and 110 mayeach be coupled to the communication network 104, e.g., through one ormore wired and/or wireless networks or other data transmissionconnections. A Plan Development client 112 may be directly coupled tothe Planning Server 102 by a data link 114. Alternatively, the PlanDevelopment client 112 may communicate with the Planning Server 102through one or more networks, including the communication network 104.The environment 100 may also include a Sales Representative or OperativeRoom Administrative client 116 coupled to the communication network 104.

It should be understood that the Radiology client 106 may be located ina different location than the hospital at which the surgery is to beperformed. For example, the Radiology client 106 may be located at animaging service facility or other laboratory or diagnostic facility thatis independent of the hospital.

It should be understood that the communication network 104 may includeone or more interconnected data networks such as a Local Area Network(LAN), a Wide Area Network (WAN), a Metropolitan Area Network (MAN), theInternet, a Virtual Private Network (VPN), a wireless network, acellular telephone network, the public switched telephone network(PSTN), etc.

As described herein, the Planning server 102 provides services to one ormore clients, i.e., electronic clients, including clients 106-112. ThePlanning server 102 may be geographically located remotely from theclients 106, 108, 110, 112 and 116. It should be understood that other,possibly far more complex, network designs and/or client-serverarchitectures may be implemented. For example, the environment 100 mayinclude other clients, such as an invoicing or billing client.

FIG. 2 is a schematic hardware illustration of the Planning server 102.The Planning server 102 may include one or more processors or otherprocessing logic, such as a central processing unit (CPU) 202, a mainmemory 204, one or more storage devices, such as a disk drive 206, aremovable medium drive 208, and one or more network interface cards(NICs) 210 that are interconnected by one or more busses, such as asystem bus 212. The main memory 204 may store a plurality of programs,libraries or modules, such as an operating system 214, and one or moreapplications running on top of the operating system 214. The removablemedium drive 208 is configured to accept and read a computer readablemedium 218, such as a CD, DVD, floppy disk, solid state drive, tape,flash memory or other medium. The removable medium drive 208 may furtherbe configured to write to the computer readable medium 218.

The Planning server 102 also may include and/or be accessible by adevice having a user input/output (I/O) 220. The user I/O 220 mayinclude a keyboard 222, a pointing device, such as a mouse 224 and adisplay 226. It should be understood that other or additional user I/Omay be provided, such as a touch screen, a touch pad, etc.

Suitable servers include the ProLiant and Integrity series of serversfrom Hewlett Packard Co. of Palo Alto, Calif., and the PowerEdge seriesof servers from Dell Inc. of Round Rock, Tex., among others.

Suitable processors may include single processor architectures, dual orquad core processor architectures, microprocessors, digital signalprocessors (DSPs), programmable logic devices, etc., or variouscombinations thereof.

Suitable operating systems 214 include the Windows series of operatingsystems from Microsoft Corp. of Redmond, Wash., the Linux operatingsystem, the MAC OS® series of operating systems from Apple Inc. ofCupertino, Calif., and the UNIX® series of operating system, amongothers.

It should be understood that the Planning server 102 of FIG. 2 is meantfor illustrative purposes only, and that the present invention may beused with other computer systems, processing systems or computationaldevices.

It should further be understood that the clients 106, 108, 110, and 112of FIG. 1 may include similar hardware components as illustrated in FIG.2 for the Planning server 102. Suitable client devices include personalcomputers (PCs), workstations, laptops, palm computers and otherportable computing devices, smart phones, tablet computers, electronicreaders (e-readers) etc.

FIG. 3 is a schematic, functional illustration of the Planning server102. The Planning server 102 may include one or more databases, such asa User database 302, and a Surgical Planning database 304. The Planningserver 102 may also include one or more modules, such as a web-basedfacility 306, a user authentication module 308, a content managementsystem 310, an email service 312, and a file system 314. The contentmanagement system 310 may include one or more modules, such as anotification engine 316, and an upload/download engine 318. The Userdatabase 302 may store a plurality of user authentication records, whichmay include user names and passwords. The User database 302 may alsoinclude contact information such as email address, telephone number,etc., among other information. The Surgical Planning database 304 mayinclude a plurality of planning records, such as planning records 320a-c. The file system 314 may include a plurality of directories,folders, and files, such as a plurality of image data files 322 a-c, anda plurality of surgeon directories or folders 324 a-c.

Clients, such as Radiology client 106 (FIG. 1 ), Surgeon client 108, ORclient 110, and Plan Development client 112 may access the Planningserver 102 via the web-based facility 306. The web-based facility 306may provide functionality and services of a web server program, such asaccepting Hyper Text Transport Protocol (HTTP) requests from clients,and providing HTTP responses to those clients.

It should be understood that the functional diagram of FIG. 3 is meantfor illustrative purposes and that other server configurations may beused with the present invention. For example, the content managementsystem 310 may include other components, such as a database managementsystem (DBMS), the user authentication module may be incorporated intothe content management system, the user and surgical planning databasesmay be combined into a single database, the image data files, may bestored in one or more of the databases, etc.

In an embodiment, the Planning server 102 may be implemented as avirtual private server. Alternatively, the Planning server 102 may beimplemented as one or more dedicated physical servers, such as two ormore servers geographically separated from each other to provideredundancy and backup to the operations of the Planning server 102.

It should further be understood that the functionality of the Planningserver 102 may be implemented in other ways. For example, thefunctionality may be distributed and/or duplicated across a plurality ofservers, such as in a server farm or cloud computing arrangement, amongothers.

Suitable web server programs for use with the present invention includeApache from the Apache Software Foundation, and Internet InformationServices (IIS) from Microsoft Corp., among others.

Suitable database management systems for use with the present inventioninclude the Oracle Database series of relational database managementsystems (RDBMSs) from Oracle Corp. of Redwood Shores, Calif., and theMicrosoft SQL® series of RDBMS from Microsoft Corp., and MySQL, amongothers.

Suitable email services include the Outlook mail client from MicrosoftCorp., the Thunderbird mail client from the Mozilla Foundation, etc. Itshould be understood that instead of or in addition to the email service312, the planning server 102 may include other communication services,such as an instant messaging service, a text messaging service, anautomated voice calling service, etc.

In an embodiment, information may be securely stored in the databases302, 304, and in the file system 314. For example, users, such asordering surgeons may need to be authenticated to the Planning server102 before being granted access to the server, and access by an orderingsurgeon may be limited to those records, image data and surgical plansassociated with that ordering surgeon. In an embodiment, each orderingsurgeon may select or be given one or more username and passwordcombinations.

Suitable content management systems include the Joomla! ContentManagement System from the Joomla Project, and the Drupal ContentManagement System from the Open Source Community, among others.Furthermore, the Planning server 102 may be a virtual private server, adedicated web host server, or a dedicated server, among other options.

FIG. 4 is a schematic, functional illustration of the Ordering Surgeonclient 108. The client 108 may include one or more applications ormodules. In particular, the client 108 may include a web browser 402,and a surgical plan viewer module 404.

FIG. 5 is a schematic, functional illustration of the Plan Developmentclient 112. The client 112 may include one or more applications ormodules. In particular, the client 112 may include a web browser 502, athree-dimensional (3D) modeling tool 503, and a surgical planning module504.

Suitable web browsers include Internet Explorer from Microsoft, Chromefrom Google Inc. of Mountain View, Calif., and Firefox from the MozillaFoundation, among others.

The web-based facility 306, user authentication module 308, contentmanagement system 310, email service 312, and file system 314 of theplanning server 102, as well as the web browser 402 and surgical planviewer module 404 of the ordering surgeon client 108, and the webbrowser 502, 3D modeling tool 503, and surgical planning module 504 ofthe plan development client 112 may each comprise registers andcombinational logic configured and arranged to produce sequential logiccircuits. In an embodiment, the web-based facility 306, userauthentication module 308, content management system 310, email service312, and file system 314 of the planning server 102, as well as the webbrowser 402 and surgical plan viewer module 404 of the ordering surgeonclient 108, and the web browser 502, 3D modeling tool 503, and surgicalplanning module 504 of the plan development client 112 are or includesoftware modules or libraries containing program instructions pertainingto the methods described herein, that may be stored on computer readablemedia, such as computer readable medium 218, and executable by one ormore processing elements, such as CPU 202. Other computer readable mediamay also be used to store and execute these program instructions. Inalternative embodiments, various combinations of software and hardware,including firmware, may be utilized to implement the present invention.

FIGS. 6A and 6B are a flow diagram of a method in accordance with anembodiment of the invention. A patient may be diagnosed with a medicalcondition that requires surgery. In preparation for the surgicalprocedure, one or more data gathering procedures may be performed. Forexample, a blood or other sample may be taken from the patient andanalyzed. Additionally or alternatively, a cardiac stress test, anelectrocardiogram, an echocardiogram, or other heart test may beperformed on the patient and the results obtained. Furthermore, one ormore digital images, such as Computed Tomography (CT), MagneticResonance Imaging (MRI), conventional radiographs (X-rays), orultrasonic images , may be taken of the patient; specifically, thatportion of the patient's anatomy on which the surgery is to beperformed. It should be understood that any diagnostic test ormeasurement, particularly one that improves dimensional understandingabout the specific portion of the patient's anatomy to be operated upon,may be performed and used for patient-specific planning.

For example, a patient may be diagnosed with hip joint failure, and mayrequire total hip replacement (THR) surgery either on the left hip, theright hip, or both hips. In this case, one or more low cost, low dose CTscans of the patient's hip may be taken by a Radiology department, whichmay or may not be located at the hospital at which the THR surgery willbe performed. The one or more digital images (radiographic, ultrasonic,magnetic, etc.) may be taken on the day of the patient's preoperativevisit or at any time prior to surgery. The one or more digital imagesmay provide three-dimensional information regarding the surface and/orstructure of the patient's hip.

A technician or other person from the hospital's radiology departmentmay utilize the Radiology client 106 to access the Planning server 102,and upload the one or more digital images to the Planning server 102.Specifically, the technician may use a web browser on the Radiologyclient 106 to navigate to a web domain hosted by the Planning server102. The web-based facility 306 of the Planning server 102 may present ahome page that includes a menu of available options for display bybrowser application at the Radiology client 106. The technician mayselect an “Upload Data” option from the menu. In response, the web-basedfacility 306 may request that the technician log in to the Planningserver 102 by presenting a login page having data fields for receiving ausername and a password. In an embodiment, the technician will havepreviously established an account that includes a username and password.Accordingly, the technician may enter this information (username andpassword) in the respective fields of the login page. In response, theuser authentication module 308 of the Planning server 102 mayauthenticate the technician, as indicated at block 602.

If the technician is authenticated to the Planning server 102, theweb-based facility 306 may establish a secure connection with theRadiology client 106, and may present a request web page for display atthe Radiology client 106. FIG. 7 is a schematic illustration of arequest web page 700 that may be generated by the web-based facility 306and presented on the Radiology client 106. The request web page 700 mayinclude a navigation menu 702 having a plurality of selectable optionsfor navigating around the website provided by the web-based facility306, such as a Home button 704, an Upload Data button 706, and aDownload Planning button 708, among others. As indicated above, therequest web page 700 may be presented in response to the technicianselecting the Upload Data option button 706 in the menu 702. The requestweb page 700 may include a request dialog 710 having plurality of fieldsfor receiving information from the technician. In an embodiment, therequest dialog 710 of the request web page 700 may include:

-   a Patient Last name field 712;-   a Patient First name field 714;-   a Patient date of birth field 716;-   a Location of the Surgery field 718 (which may have a drop down menu    of available locations such as left side, right side or both in the    case of THR surgery);-   a Date of First Surgery field 720;-   a Date of Second Surgery field 722;-   an Assigned Surgeon field 724; and-   a Data to Upload field 726.

It should be understood that additional or other information, such asthe sex of the patient, the age of the patient, etc., may be requested.

The technician enters the requested information in the fields 712-726.In the Assigned Surgeon field 724, the technician may type in thesurgeon's name. The Data to upload field 726 may include a “Browse” orother command button 728, which if selected by the technician, presentsa dialog box (not shown) that allows the technician to navigate throughthe directories and folders located on the Radiology client 106 (or onother computers, servers or other data processing machines accessiblefrom it) in order to select one or more data files or objects to beuploaded to the Planning server 102.

The request page 700 may also include a Submit or other command button730 that may be selected by the technician, after entering the requestedinformation, and identifying the one or more data files or objects. Inresponse to entering the submit command, the request for a surgicalplan, created by the technician, is received at the planning server 102,as indicated at block 604.

The content management system 310 may cooperate with the surgicalplanning database 304 to create a new record 320 for the request, asindicated at block 606. In addition, the upload/download engine 318 mayupload the one or more data files or objects, such as image files,identified in the request from the Radiology client 106, and store themin an image data file 322 in the file system 314, as indicated at block608.

FIG. 8 is a schematic illustration of a planning record 320. Theplanning record 320 may include a plurality of fields or cells forstoring information. Specifically, the planning record 320 may include aPlan Identifier (ID) field 802 that contains a value, such as a number,that is automatically generated by the content management system 310 touniquely identify the record 320 in the surgical planning database 304.The planning record 320 may also include a Submission User ID field 804,which may be automatically populated by the content management system310 with the username or other identifier of the person submitting therequest, e.g., the technician. The planning record 320 may also includea Submission date field 806, which may be automatically populated by thecontent management system 310 with the date the request is submitted tothe Planning server 102. The planning record 320 may also include aPatient Last name field 808, a Patient First name field 810, and aPatient date of birth (dob) field 812, which may be populated withinformation from the request by the content management system 310.

The planning record 320 may also include a Site of Surgery field 814,which may be populated with information from the request, for example,information entered into the Location field 718 (FIG. 7 ) of therequest. For example, for THR surgery, field 814 may contain “right”,“left”, or “both”. The planning record 320 may also include one or morefields for storing the date(s) of the surgery, such as a Date of Surgery1 field 816, and a Date of Surgery 2 field 818, which may be populatedwith information contained in the request, such as information from theDate of First and Second Surgery fields 720, 722 of the request. Theplanning record 320 may also include the name of the surgeon who willperform the surgery in a Name of Surgeon field 820, which may bepopulated with information from the Assigned Surgeon field 724 of therequest. The planning record 320 may also include a path/file name field822, which contains the path and file name of the one or more data filesor objects, such as images, uploaded to the Planning server 102. Therecorded path and file name may identify the location of the data fileor object, as uploaded and stored in the file system 314 of the Planningserver 102.

The planning record 320 may also include additional fields that arepopulated once a surgical plan has been created in response to therequest. For example, the record 320 may include a Planner User ID field824 that contains an ID assigned to the surgical planner that createsthe surgical plan for the request. The planning record 320 may alsoinclude a path/file name of surgical plan 1 field 826, and a path/filename of surgical plan 2 field 828, which may be loaded with the pathsand file names of surgical plans created for surgical procedureassociated with the record 320. The planning record 320 may also includea Surgeon ID field 830, which may be loaded with an ID assigned to thesurgeon who will be performing the surgical procedure, and who will beable to access the first and second surgical plans through the Planningserver 102.

It should be understood that the planning record 320 may include otherfields, such as a status field, which may be used to indicate whether aparticular record is in a pending state, i.e., awaiting a surgical plan,or in a completed state, i.e., associated with one or more surgicalplans.

As indicated, the fields of the planning record 320 may be populated bythe content management system 310 based on information contained in therequest, and on information received from the surgical planner whocreates the surgical plan.

The content management system 310 in cooperation with the email service312 may issue a confirmation email to the technician (and/or to thesurgeon identified by the technician) indicating that a request for asurgical plan has been received by the Planning server 102, as indicatedat block 610. The content management system 310 and email service 312may also issue a notification to a planning surgeon that a new requesthas been received, as indicated at block 612.

It should be understood that a request for a surgical plan may be madeby the surgeon who will be performing the surgical procedure through theOrdering Surgeon client 108, instead of by the technician. In a furtherembodiment, the technician and/or ordering surgeon may append additionalinformation to the request, such as notes prepared by the surgeonregarding particular aspects of the procedure itself, or of the patient,such as the position of the patient during the surgery, one or moredesired locations or orientations of prosthetic components, such as anacetabular cup, etc.

It should also be understood that the request may be edited, forexample, to change the date or location of the proposed surgery.Further, a new request may be made that refers to a previously submittedimage data set. For example, if a CT study was submitted for a THRsurgery on the patient's right side, and subsequently, surgery on theleft side, for which the CT study is also useful, is desired, a planningrequest may be submitted with reference to the surgery that waspreviously performed so that the correct image data may be retrievedwithout having to upload the data a second time.

Next, a surgical planner, such as an experienced surgeon or otherperson, may utilize the Plan Development client 112 to access the newlycreated request. In particular, the surgical planner may log into thePlanning server 102, and access the new request. In an embodiment, thesurgical planner may enter the patient's name, and the contentmanagement system 310 may query the surgical planning database 304 forthe record 320 associated with that patient. Alternatively, the surgicalplanner may cause other searches to be performed, such as a search basedon the name of the surgeon performing the procedure, a search based onthe date of the procedure, etc. In addition, rather than perform asearch, the surgical planner may logon to the Planner server 102 andview all open or pending requests for surgical plans. The request, aspresented on the Plan Development client 112, may include a hyperlinkfor the one or more image files. In response to the surgical plannerselecting this hyperlink, the upload/download engine 318 may downloadthe one or more data files or objects, such as one or more image datafiles 322, from the file system 314 to the Plan Development client 112,as indicated at block 614. The surgical planner may then utilize the oneor more files or objects, e.g., images, to create a surgical plan forthe procedure, as indicated at block 616.

In an embodiment, the surgical planner may utilize the 3D modeling tool503 of the Plan Development client 112 to create a computer-generated,three-dimensional model of the patient's anatomy, such as the patient'ship, based on the one more digital images uploaded to the Planningserver 102 from the Radiology client 106.

The Plan Development client 112 also may run surgical planning software,such as the surgical planning module 504 (FIG. 5 ). The surgical planneroperating the Plan Development client 112 may utilize the surgicalplanning module 504 to create an electronic surgical plan for thesurgical procedure that is to be performed on the patient. For example,the surgical planner may create a plan for inserting one or moreprosthetic or surgical components, such as an acetabular cup component,into the patient's hip during THR surgery, using one or more surgicalinstruments.

In an embodiment, the surgical planner operating the surgical planningmodule 504 may establish a standard pelvic coordinate system, such asthe anterior pelvic plane, for the 3-D, computer-generated model of thepelvis. A patient-specific coordinate system for use by the one or moresurgical instruments may also be established, for example, by usingthree points on the 3-D model of the patient's pelvis.

A suitable surgical instrument and its use is described in U.S. Pat. No.8,267,938 issued Sep. 18, 2012 for a Method and Apparatus forDetermining Acetabular Component Positioning by Stephen Murphy, which ishereby incorporated by reference in its entirety.

In an embodiment, the surgical planning module 504 is used by thesurgical planner operating the Plan Development client 112 to calculateone or more inputs and/or adjustments to be made on the one or moresurgical instruments. The inputs and/or adjustments may be based, atleast in part, on the 3-D model of the pelvis that was created, on someor all of the patient-specific information, and/or on statisticalinformation known to or accessible by the surgical planner. For example,the inputs and/or adjustments may be used in order to make a directionindicator of a surgical instrument point in a direction of acetabularcup orientation, as desired by ordering surgeon and/or as intended bythe surgical planner. Furthermore, knowledge of supine and/or standingpelvic tilt, which may be provided as part of the patient-specificinformation, can be incorporated in the adjustments to be made to thesurgical instrument.

The surgical plan may thus include a series of inputs or adjustments tobe made to one or more surgical instruments before or during theprocedure. The surgical plan may further include instructions forsetting up and using the one or more surgical instruments during theprocedure. In other embodiments, the surgical plan may be or may includemachine instructions, such as executable code, for operating one or moremachines, such as a surgical tool or other machine to assist during thesurgical procedure. The surgical plan may even include machineinstructions to be executed by a robotic surgical tool that will performall or part of the procedure. For example, the surgeon may register abody part of the patient in accordance with one or more requirements,and once the body part is registered, an active, semi-active, or hapticrobot may be used to perform all or part of the planned procedureoperating according to instructions in the surgical plan or a locallyupdated surgical plan according to additional desires input by thesurgeon. The robot, moreover, may be controlled from the Planningserver, for example, through the OR client 110 or another dataprocessing device. In addition to controlling a surgical robot, thesurgical plan may provide instructions for controlling a free-handsurgical device, such as a rotating tool, to turn on when it is in alocation where cutting is to be performed and either turn off or throughdeployment of a protective sheath when it is in a location where cuttingshould not take place.

Exemplary surgical robots include the surgeon-controlled robotic armsfrom Mako Surgical Corp. of Fort Lauderdale, Fla. Exemplary free-handtools include the freehand sculptor from Blue Belt Technologies, Inc. ofPittsburgh, Pa.

In an embodiment, the surgical plan may include one or more 3D printerfiles that may be used to operate a locally controlled 3D printer tocreate a single-use, patient-specific instrument or prostheticcomponent, such as a component designed to mate with the patient'sanatomy, such as the patient's hip, knee or other joint. For example,the component may fit uniquely onto patient-specific anatomy in oradjacent to a joint of the patient, and provide the specific orientationand location of a drill guide to be used during the surgical procedureon the patient. The surgeon or a technician may utilize the one or more3D printer files to run the 3D printer and construct thepatient-specific component. The 3D printer may be located at thehospital at which the surgery is to be performed or it may be located atanother facility, such as a quality-controlled manufacturing facilitythat is local to the hospital.

A suitable component or template is described in U.S. Pat. No. 8,986,309issued Mar. 24, 2015 for an ACETABLULAR TEMPLATE COMPONENT AND METHOD OFUSING SAME DURING HIP ARTHROPLASTY by Stephen Murphy, which is herebyincorporated by reference in its entirety.

Once completed, the electronic surgical plan created at the PlanDevelopment client 112 by the surgical planner may transmitted to thePlanning server 102, and stored on the Planning server 102, as indicatedat block 618. The electronic surgical plan may be stored in therespective ordering surgeon folder 324 in a secure manner, so that it isaccessible only by the ordering surgeon and/or his staff. Specifically,the surgical planner may access and login to the Planning server 102from the Plan Development client 112.

FIG. 9 is schematic illustration of a surgical plan upload web page 900for presentation on the Plan Development client 112. The surgical planupload page 900 includes the navigation menu 902 having a plurality ofnavigation buttons, such as a Home button 904, an Upload Data button906, a Download Planning button 908, an Administrator (ADMIN) CompleteSubmissions button 910, and an ADMIN Edit Submissions button 912. Theupload page 900 may be presented in response to the selection of anADMIN complete submissions button 910 by the surgical planner afterlogging in. The web page 900 may include a first region 914 that listsone or more requests for surgical plans that are pending. For example,first region 914 may include a plurality of entries, such as entries 916a-c, where each entry corresponds to a pending request for a surgicalplan. To associate a completed plan with a particular request, theplanning surgeon may select the desired request, for example entry 916a, from the first region 914. Selection may be made with a mouse orother pointing device.

In response, the web-based facility 306 may present a dialog box 918 forreceiving a designation of the surgical plan for the identified record.The dialog box 918 may include one or more fields for receivinginformation from the planning surgeon operating through the PlanDevelopment client 112. Specifically, the dialog box 918 may include aSurgical Plan field 920, a Designated Surgeon field 922, and an AssignedSurgeon ID field 924. The surgical planner enters the path and file namefor the surgical plan that was created in the Surgical Plan field 908.The Surgical Plan field 908 may include a “Browse” or other commandbutton 926, which if selected by the surgical planner, presents a dialogbox (not shown) that allows the surgical planner to navigate through thedirectories and folders located on the Plan Development client 112 (oron computers, servers or other data processing machines accessible fromit) in order to select one or more surgical plans to be uploaded to thePlanning server 102.

The Designated Surgeon field 922 may present the name of the surgeon asentered by the technician in the Assigned Surgeon field 724 of therequest web page 700, and stored in field 820 of the planning record320. In an embodiment, the planning surgeon may utilize the informationpresented in the Designated Surgeon field 922 to identify the surgeonperforming the procedure on the patient by his or her user name (orother registered name) within the Assigned Surgeon ID field 924. A dropdown button 928 may be provided that, when selected, provides a list(not shown) of all registered users to assist the surgical planner inselecting the correct name.

The surgical plan upload page 900 may also include a Submit or othercommand button 930 that may be selected by the surgical planner, afteridentifying the surgical plan file and entering the requestedinformation. In response to entering the submit command 930, theupload/down engine 918 uploads the surgical plan created by the planningsurgeon to the planning server 102. In addition, the content managementsystem 310 may populate the planner user ID field 824 (FIG. 8 ), thepath/file name of surgical plans fields 826, 828, and the surgeon IDfield 830 of the respective planning record 320.

In an embodiment, the surgical plan may be stored in an operatingsurgeon folder 324 associated with the surgeon that will be performingthe procedure.

The content management system 310 cooperates with the email service 312to generate and send one or more notifications to the ordering surgeon,informing him or her that a surgical plan has been prepared and is nowavailable for download from the Planning server 102, as indicated atblock 620.

The ordering surgeon may utilize the Ordering Surgeon client 108 and/orthe OR client 110 to access and download the surgical plan, which isstored in his or her operating surgeon folder 324, as indicated at block622.

FIG. 10 is schematic illustration of a surgical plan download web page1000 for presentation on the Ordering Surgeon client 108 and/or theOperating Room client 110. The surgical plan download page 1000 may bepresented in response to the selection of a Download planning button,such as button 908 (FIG. 9 ) on a navigation menu, such as menu 902. Theweb page 1000 may include one or more search fields, such as a PatientLast name search field 1002, and a Planned side search field 1004. Theweb page may also include a Submit or other command button 1006, and asurgical plan listing region 1008. The surgeon may search for aparticular plan by entering search criteria in the one or more searchfields 1002, 1004, and selecting the submit button 1006. In response,the content management system 310 searches the plans in the respectiveoperating surgeon folder 324, and presents the matching plan(s) in thesurgical plan listing region 1008. In an embodiment, the surgeon mayleave the one or more search fields 1002, 1004 blank and simply selectthe Submit button 1006. In response, the content management system 310may provide a listing of all of the surgical plans from the respectiveoperating surgeon folder 324 in the surgical plan listing region 1008.

Each surgical plan listed in the surgical plan listing region 1006 maybe included in an entry, such as entries 1010 a, 1010 b that includeinformation concerning the plan, such as the patient's first and lastname, the area to be operated on, e.g., left or right side for a THRoperation, etc. In addition, each entry may include a hyperlink that islinked to the respective surgical plan as sorted in the file system 314of the Planning server 102. To download a desired surgical plan, theordering surgeon may select the hyperlink, e.g., StevensRtPlan.zip fromentry 1010 a. In response, the upload/download engine 318 of thePlanning server 102 may present a dialog box at the Order Surgeon client108 that allows the requesting surgeon to select a particular directorypath/file name for storing the surgical plan on the Ordering Surgeonclient 108 and/or the Operating Room client 110. The upload/downloadengine 318 may then download the selected surgical plan into theidentified directory/folder path.

In an embodiment, the Ordering Surgeon client 108 may run a viewersoftware module that presents the electronic surgical plan, e.g., on adisplay of the Ordering Surgeon client 108. The ordering surgeon mayoperate the viewer software to review and/or adjust the surgical planbefore or even during the surgical procedure. For example, a combinedanteversion goal can be adjusted by the ordering surgeon once theanteversion of the femoral stem is determined in surgery. That is, theordering surgeon may select and/or adjust one or more surgicalinstruments as provided in the surgical plan. In addition, to the extentthe surgical plan includes one or more executable files, the surgeon ora technician may load the executable files in a respective machine ordevice for execution during the surgical procedure, or may use the filesin a 3D printer to build a patient-specific component at the hospital orat a local manufacturing facility.

Alternatively, the Planning server 102 or another server may run theviewer software, and the ordering surgeon may access it through a webbrowser application. In this embodiment, the surgical plan is notdownloaded to the Ordering Surgeon client 108 or the OR client 110.Instead, the surgical plan remains on the Planning server 102 and isaccessed through the web-based facility 306, and a surgical plan viewmodule, which may be similar to module 404, running on the Planningserver 102.

The ordering surgeon may load the surgical plan on the Operating Roomclient 110, and access the electronic surgical plan during the surgicalprocedure. Alternatively, the ordering surgeon may use the OperatingRoom client 110 to access the electronic surgical plan from the Plannerserver 102. Further, the surgeon or a technician may establish a datacommunication link or channel to a robotic or other surgical device or a3D printer, which may then be controlled remotely through instructionsissued from the Planning server according to the surgical plan.

FIG. 11 is a schematic illustration of a surgical plan 1100 as presentedby the surgical plan view module 404 (FIG. 4 ). The surgical plan 1100may have a Load Plan command button 1102 for selecting a plan to beopened by the module 404. In response to a user selecting the Load Planbutton 1102, the module 404 may display a dialog box (not shown)allowing the user to navigate available directories and files and selecta surgical plan file to be opened. The selected plan to be opened may bethe surgical plan downloaded to the client on which the module 404 isrunning, such as the OR client 110, the Ordering Surgeon client 108, orthe Sales Representative client 110, among others. The surgical plan 110may also include a first region 1104 containing information regardingthe particular plan, such as a Patient name entry 1106, a Patient dateof birth entry 1108, a region to be operated on entry 1110, for examplethe patient's right side, and a Date of Planning entry 1112.

The surgical plan may include a viewing area 1114. The viewing area mayinclude an image of the patient's anatomy to be operated on. Forexample, for THR surgery, the viewing area may include athree-dimensional image of the patient's pelvis 1116. In addition, animage of a surgical instrument to be used during the procedure, such asinstrument image 1118, may be included in the viewing area 1114. Theinstrument represented by image 1118 may be a mechanical instrumenthaving a plurality of parts or elements. For example, the instrument mayhave three legs 1120 a-c, two arms 1122 a-b, a guide pin supportstructure 1124, and a guide pin 1126. The viewing area 1114 may alsoinclude one or more reference elements, such as an Anterior/Posteriorplane 1127 of the pelvis 1116.

The surgical plan 1100 also may include a planning data region 1128 thatincludes one or more data elements determined by the surgical planner,and included in the surgical plan. In an embodiment, the data elementsspecify one or more adjustments to be made to the surgical instrument1118, for example, to fit the surgical instrument to the particularpatient, and to achieve one or more objectives of the surgicalprocedure. For example, the planning data region may include a pindistance data value 1130. This value may specify the distance betweenlegs 1120 a and 1120 c and between legs 1120 a and 1120 b. The orderingsurgeon may adjust the physical instrument used during surgery toachieve this distance by adjusting the two arms 1122 a, 1122 b of theinstrument 1118 to the specified pin distance value, e.g., “107.7”. Theplanning data region 1128 may also include an In Plane data value 1132.This value may specify the angle, e.g., 33 degrees, from arm 1122 a thatthe guide pin support structure 1124 is to be located. The planning dataregion 1128 may further include an Off Plane data value 1134. This valuemay specify the angle, e.g., 20 degrees, that the guide pin 1126 israised above a plane defined by the two arms 1122 a, 1122 b.

The surgical plan 1100 may also include a surgical objectives region1136, which may specify one or more objectives to be achieved by thesurgical plan. For example, in THR surgery, one of the surgicalobjectives may be the orientation of an acetabular cup inserted into thepatient's acetabular. The orientation, moreover, may be specified interms of anteversion and inclination. Accordingly, the surgicalobjections region 1136 may include an operative anteversion entry 1138,and an operative inclination entry 1140. By adjusting the surgicalinstrument 1118 according to the values specified in the planning dataregion 1128, the guide pin 1126 on the instrument 1118 may be used bythe ordering surgeon during the procedure in order to insert theacetabular cup in accordance with the surgical objectives specified inthe surgical objectives region 1136, namely an anteversion of 30 and aninclination of 36. During the creation of the surgical plan, thesurgical planner may determine the one or more surgical objectives, andthe one or more data plan elements for achieving the objectives.

In an embodiment, the surgical plan may be a preliminary plan. That is,one or more of the surgical objectives may be modified by the orderingsurgeon. That is, the ordering surgeon may change one or more of thesurgical objectives. For example, the ordering surgeon may modify theanteversion and/or the inclination. The surgical objectives region 1136may include one or more sliders, data entry boxes, arrows, or othergraphical elements, such as slider elements 1142 and 1144 that may beused to modify the respective surgical objectives. In an embodiment, ifthe ordering surgeon changes one or more of the surgical objectives,such as the anteversion, the surgical plan view module 404 may beconfigured to recalculate one or more of the data elements in theplanning data region 1128 in order to achieve the new objective. Forexample, if the ordering surgeon changes the desired anteversion orinclination, then the viewer module 404 may compute new in plane and offplan values to achieve those new desired surgical objectives.

It should be understood that one or more objectives or elements of thesurgical plan may be locked, such as the pin distance, while otherobjectives or data plan elements may be modifiable by the orderingsurgeon.

In another embodiment, the surgical objectives and/or the planning datavalues may be fixed.

In an embodiment, an entity, such as a corporation, may run the surgicalplanning services of the present invention. That is, the surgicalplanning company may own and/or rent the Planning server and the PlanDevelopment client. The surgical planning company may also own and/orlicense software running on the Planning server and Plan Developmentclient. The surgical planning company may charge ordering surgeons,hospitals, patients, medical insurers or others for the service ofcreating an electronic, patient-specific surgical plan, and use ofassociated instruments that may reside or be shipped to or printed atthe facility to carry out the surgical plan, such as a mechanical orother surgical instrument or a component.

Using the surgical plan, the ordering surgeon may perform the surgicalprocedure on the patient, as indicated at block 624 (FIG. 6B).

Following the surgical procedure, a notification may be sent to thePlanning server 102, indicating that the procedure was performed and thedate it was performed, as indicated at block 626. The notification maybe sent by a sales representative from the Sales Rep client 116, or bythe ordering surgeon. The notification may identify the patient by nameand date of birth. Alternatively or additionally, the notification mayidentify the surgical procedure by the unique plan number assigned tothe surgical plan. The Planning server 102 receives the notification, asindicated at block 628. In response to the notification, the contentmanagement system 310 may automatically generate an invoice for servicesrelating to the creation of the surgical plan, as indicated at block630. The content management system 310 may cooperate with the emailservice 312 to send the invoice automatically to the ordering surgeon orhis or her hospital or medical center, as also indicated at block 630.

In an embodiment, the content management system 310 may cause a dialogbox to appear at the time the surgical plan is downloaded by theordering surgeon, for example, to the Ordering Surgeon client 108 or theOperating Room client 110. The dialog box may include a data entry fieldrequesting the name of the facility at which the surgical procedure willbe performed, e.g., the name of the hospital or medical facility. Thesurgeon may enter the name, and submit this information to the Planningserver 102.

The content management system 310 may consider the downloading of thesurgical plan by the ordering surgeon as a “billable event”. In thiscase, upon receiving the name of the hospital or medical facility atwhich the surgical procedure will be performed, the content managementsystem 310 may generate automatically an invoice to the identifiedhospital or medical facility. The content management system 310 mayinclude within the generated invoice a price that reflects a negotiatedor agreed-on price with the particular hospital or medical facility.Specifically, the content management system 310 may store negotiated oragreed-on prices with a plurality of different hospitals and medicalfacilities. This information may be stored, for example, in the filesystem 314. The content management system 310 in cooperation with theemail service 312 may generate an email including the invoice and issueit to the hospital or medical facility identified by the orderingsurgeon. Payments received at the Planning server 102 may be reconciled,and paid invoices closed. The content management system 310 mayautomatically generate and issue a notification concerning unpaidinvoices, for example, invoices un-paid after 30 days, 60 days or someother period.

A copy of the invoice may also be stored in the file system 314. Theinvoice may be assigned an invoice number by the content managementsystem 310. Using the invoice number or other identifying information,the content management system 310 may reconcile electronic paymentsreceived at the Planning server 102, such as direct bank payments, tothe invoices. An administrator may periodically query the Planningserver 102 to identify any outstanding invoices.

In an embodiment, the charge for creating one or more patient-specificsurgical plans can be incorporated into a charge for the one or moresurgical instruments utilized during the surgical procedure.

The foregoing description of embodiments is intended to provideillustration and description, but is not intended to be exhaustive or tolimit the invention to the precise form disclosed. Modifications andvariations are possible in light of the above teachings or may beacquired from a practice of the invention. For example, while a seriesof acts has been described above with respect to the flow diagrams, theorder of the acts may be modified in other implementations. Further,non-dependent acts may be performed in parallel. Also, the term “user”,as used herein, is intended to be broadly interpreted to include, forexample, a computer or data processing system or a user of a computer ordata processing system, unless otherwise stated.

Further, certain embodiments of the invention may be implemented aslogic that performs one or more functions. This logic may behardware-based, software-based, or a combination of hardware-based andsoftware-based. Some or all of the logic may be stored in one or moretangible non-transitory computer-readable storage media and may includecomputer-executable instructions that may be executed by a computer ordata processing system, such as server system 102. Thecomputer-executable instructions may include instructions that implementone or more embodiments of the invention. The tangible non-transitorycomputer-readable storage media may be volatile or non-volatile and mayinclude, for example, flash memories, dynamic memories, removable disks,and non-removable disks.

No element, act, or instruction used herein should be construed ascritical or essential to the invention unless explicitly described assuch. Also, as used herein, the article “a” is intended to include oneor more items. Where only one item is intended, the term “one” orsimilar language is used. Further, the phrase “based on” is intended tomean “based, at least in part, on” unless explicitly stated otherwise.

The foregoing description has been directed to specific embodiments ofthe present invention. It will be apparent, however, that othervariations and modifications may be made to the described embodiments,with the attainment of some or all of their advantages. For example, thesurgical plan may be a template that is completed by the orderingsurgeon. Therefore, it is the object of the appended claims to cover allsuch variations and modifications as come within the true spirit andscope of the invention.

What is claimed is:
 1. A method comprising: analyzing patient-specificinformation and statistical information to determine at least one of adimension, a size, or a shape of a portion of the patient's anatomy;calculating one or more adjustments to be made to an adjustable,mechanical surgical instrument to fit the adjustable, mechanicalsurgical instrument to the portion of the patient's anatomy, wherein thecalculating is based on the at least one of the dimension, the size, orthe shape determined through the analyzing patient-specific informationand statistical information; generating an electronic surgical plan forthe patient, the electronic surgical plan including instructions forperforming a surgical procedure on the patient, where the instructionsare customized to the patient, and specify the one or more adjustmentsto be made to the adjustable, mechanical surgical instrument; anddisplaying, on a computer display, at least a portion of the electronicsurgical plan including the one or more adjustments to be made to theadjustable, mechanical surgical instrument, wherein the adjustable,mechanical surgical instrument is suitable for reuse with differentpatients based on different adjustments that are made to the adjustable,mechanical surgical instrument.
 2. The method of claim 1 furthercomprising: notifying an ordering surgeon of the availability of theelectronic surgical plan.
 3. The method of claim 2 wherein the orderingsurgeon is notified by at least one of an email message, a text message,or a voice message.
 4. The method of claim 1 wherein the electronicsurgical plan further includes one or more instructions for constructinga patient-specific component for use during the surgical procedure. 5.The method of claim 1 wherein the patient's anatomy includes a hip ofthe patient, and the one or more adjustments of the electronic surgicalplan cause the adjustable, mechanical surgical instrument to fit to thehip of the patient.
 6. The method of claim 5 further comprising fittingthe adjustable, mechanical surgical instrument to the hip of the patientto perform the surgical procedure.
 7. The method of claim 1 furthercomprising modifying the electronic surgical plan by an orderingsurgeon.
 8. The method of claim 1 wherein the one or more adjustments ofthe surgical plan specify a setting for a guide pin for orienting aprosthetic component inserted into the patient's anatomy.
 9. The methodof claim 1 wherein the instructions include machine instructions andwherein the adjustable, mechanical instrument is robotic, the methodfurther comprising: adjusting the adjustable, mechanical surgicalinstrument based on the adjustments and utilizing the machineinstructions, and utilizing the machine instructions by the adjustable,mechanical instrument to perform the surgical procedure.
 10. A systemfor generating an electronic surgical plan, the system comprising: oneor more memories storing patient-specific information and statisticalinformation; and one or more processors in communicating relationshipwith the one or more memories, the one or more processors configured to:analyze the patent-specific information and the statistical informationto determine at least one of a dimension, a size, or a shape of aportion of the patient's anatomy; calculate one or more adjustments tobe made to an adjustable, mechanical surgical instrument to fit theadjustable, mechanical surgical instrument to the portion of thepatient's anatomy, wherein the calculate is based on the at least one ofthe dimension, the size, or the shape determined by the analyzing thepatent-specific information and the statistical information; generate anelectronic surgical plan for the patient, the electronic surgical planincluding instructions for performing a surgical procedure on thepatient, where the instructions are customized to the patient, andspecify the one or more adjustments to be made to the adjustable,mechanical surgical instrument; and display, on a computer display, atleast a portion of the electronic surgical plan including the one ormore adjustments to be made to the adjustable, mechanical surgicalinstrument, wherein the adjustable, mechanical surgical instrument issuitable for reuse with different patients based on differentadjustments that are made to the adjustable, mechanical surgicalinstrument.
 11. The system of claim 10 wherein the one or moreprocessors are further configured to: fit the adjustable, mechanicalsurgical instrument to a hip of the patient to perform the surgicalprocedure.
 12. The system of claim 10 wherein the one or moreadjustments of the surgical plan specify a setting for a guide pin fororienting a prosthetic component inserted into the patient's anatomy.13. The system of claim 10 wherein the instructions include machineinstructions and the adjustable, mechanical instrument is robotic, andwherein the one or more processors are further configured to: adjust theadjustable, mechanical surgical instrument based on the adjustments andutilizing the machine instructions, and utilize the machine instructionsby the adjustable, mechanical instrument to perform the surgicalprocedure.
 14. One or more non-transitory computer-readable mediacomprising program instructions, the program instructions when executedby a processing element operable to: analyze patient-specificinformation and statistical information to determine at least one of adimension, a size, or a shape of a portion of the patient's anatomy;calculate one or more adjustments to be made to an adjustable,mechanical surgical instrument to fit the adjustable, mechanicalsurgical instrument to the portion of the patient's anatomy, wherein thecalculate is based on the at least one of the dimension, the size, orthe shape as determined by the analyzing patient-specific informationand statistical information; generate an electronic surgical plan forthe patient, the electronic surgical plan including instructions forperforming a surgical procedure on the patient, where the instructionsare customized to the patient based on the one or more electronic datafiles, and specify the one or more adjustments to be made to theadjustable, mechanical surgical instrument; and display, on a computerdisplay, at least a portion of the electronic surgical plan includingthe one or more adjustments to be made to the adjustable, mechanicalsurgical instrument, wherein the adjustable, mechanical surgicalinstrument is suitable for reuse with different patients based ondifferent adjustments that are made to the adjustable, mechanicalsurgical instrument.
 15. The non-transitory computer-readable medium ofclaim 14 wherein the one or more adjustments of the surgical plandetermine a setting for a guide pin for orienting a prosthetic componentinserted into the patient's anatomy.